(268 days)
Not Found
No
The device is a contact lens lubricant eye drop solution, and the summary does not mention any AI or ML components.
No
The device is described as a "contact lens care product" and "lubricants" intended to "moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes." It is specifically compared to "other 510k-cleared lens drop lubricants" and a predicate device which is also a "Lubricant Eye Drops." While it relieves minor irritation, discomfort, dryness, blurring, and itchiness, these are symptoms managed through lubrication and moisturizing rather than actively treating a disease or restoring function, distinguishing it from a therapeutic device.
No
This device is a contact lens lubricant designed to alleviate symptoms of dry eyes and discomfort while wearing contact lenses. It does not diagnose any conditions.
No
The device is an eye drop solution, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to rewet and lubricate contact lenses and relieve symptoms of dry eyes while wearing contact lenses. This is a direct application to the eye and contact lens, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "contact lens care product (lubricants)" and a "contact lens rewetting solution." These descriptions align with devices used externally or applied directly, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in a sample
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis
The device falls under the category of a medical device intended for direct application to the eye and contact lens for comfort and symptom relief.
N/A
Intended Use / Indications for Use
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
Product codes (comma separated list FDA assigned to the subject device)
MRC, LPN
Device Description
The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.
The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.
OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:
- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Biocompatibility evaluation and biocompatibility testing of MaxiTears CONTACTS PF lens drop . solutions for patient-contacting materials including chemical characterization, genotoxicity, cytotoxicity, sensitization and irritation reactivity, subacute and systemic toxicity per ISO 10993-1, 3, 5, 10, 11, 12, 17, 18 ; PASSED all testing
- Cleaning and Sterilization Testing MaxiTears CONTACTS PF lens drop solutions are not sterilized in . their final packaging. The sterile bulk solution is stored under aseptic conditions within the storage tank and then for the filling process pushed through a sterile polypropylene filter 1.2µm to the sterilized blow-fill-machine under sterile nitrogen pressure. The sterility of the final solution is preserved by an overpressure sterile nitrogen flow. The filling is performed into natural plastic pellets, made of transparent LDPE, which were extruded at temperatures between 160 and 190 ℃. The molds which leave the extruder, immediately transformed into the 0.4ml Single Dose Unit (SDU)-blocks for MaxiTears CONTACTS PF. The blown SDU are sterile due to the high temperature applied. The devices are classified as Established Category A per the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Sterility tests are performed according USP39-NF34 ; PASSED all testing
- In vitro lens compatibility testing testing demonstrates physical product compatibility from . MaxiTears CONTACTS PF lens care solutions with both soft (hydrophilic) and RGP contact lenses according ISO 1198 and ISO 18369-2, -3; PASSED all testing
- . Shelf Life Testing - shelf life determination is based on real time as well as open vial (in-use) stability studies of the MaxiTears CONTACTS PF lens drop solutions performed in compliance with ICH guidance document Q1A and with ISO 13212:2014 Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life; PASSED all testing
- Storage and Transport Testing include transport validation under routine conditions with different lots . of manufactured MaxiTears CONTACTS PF assembled in different packaging variants to maintain integrity through normal shipping and handling; PASSED all testing
- Usability engineering testing per IEC 62366; PASSED all testing
- Risk Management per ISO 14971 and EN ISO 14971; all requirements were met and risks reduced as . far as possible.
Clinical Performance Data:
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. This type of device, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2019
Omnivision AG % Oliver Eikenberg, PhD Senior Consultant, QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K182984
Trade/Device Name: MaxiTears CONTACTS PF Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC, LPN Dated: June 14, 2019 Received: June 17, 2019
Dear Dr. Eikenberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182984
Device Name MaxiTears® CONTACTS PF
Indications for Use (Describe)
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| Research Use Only; RUO-Not for use in Diagnostic ProceduresFor In Vitro Diagnostic Use; IVD-Subject to Certain Limitations | Research Use Only; RUO-Not for use in Diagnostic Procedures | For In Vitro Diagnostic Use; IVD-Subject to Certain Limitations | ||
| Research Use Only; RUO-Not for use in Diagnostic Procedures | ||||
| For In Vitro Diagnostic Use; IVD-Subject to Certain Limitations |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
MaxiTears CONTACTS PF
K182984
1. Submission Sponsor
Omnivision AG Zentralstrasse 100 Neuhausen am Rheinfall, Schaffhausen CH-8212 Switzerland Contact: Joachim Kolter, Management Representative (QMB)
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327.9997
Contact: Oliver Eikenberg, PhD
Title: Senior Consultant, Quality & Regulatory Affairs
3. Date Prepared
07/16/2019
4. Device Identification
| Trade/Proprietary Name: | MaxiTears CONTACTS PF |
|---|---|
| Common/Usual Name: | Lens Care products |
| Classification Name: | Rigid Gas Permeable (RGP) Contact Lens Care Products |
| Soft (hydrophilic) Contact Lens Care Products | |
| Regulation Number: | §886.5918 , §886.5928 |
| Product Code: | MRC, LPN |
| Device Class: | Class II |
| Classification Panel: | Ophthalmic |
4
5. Legally Marketed Predicate Device(s)
PREDICATE: K032030, blink™ CL Lubricant Eye Drops, manufactured by Advanced Medical Optics, CA, USA
6. Indication for Use Statement
MaxiTears® CONTACTS PF eve drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.
7. Device Description
The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.
The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.
OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:
- MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.
8. Substantial Equivalence Discussion
The following table compares the "MaxiTears® CONTACTS PF" to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
5
| Subject Device | Predicate Device | Device Comparison | |
|---|---|---|---|
| Manufacturer | Omnivision AG (SWITZERLAND) | Advanced Medical Optics, (USA) | |
| Trade Name | MaxiTears® CONTACTS PF | blink™ CL Lubricant Eye Drops | |
| 510(k) Number | K182984 | K032030 | NA |
| Product Code | MRC, LPN | MRC, LPN | Same |
| Regulation Number | 21 CFR 886.5918 Rigid Gas Permeable (RGP) Contact Lens Care Products | ||
| 21 CFR 886.5928 Soft (hydrophilic) Contact Lens Care Products | Same | ||
| Regulation Panel | Ophthalmic | Same | |
| Principle of | |||
| Operation | Physical mode, Works inside of the eye providing moisturization and | ||
| lubrication for Soft & RGP Contact Lenses | Same | ||
| Over the Counter Use | Yes | Yes | Same |
| Multi or Single-Use | Single-use variants | Multi-use only | Similar |
| Variants | MaxiTears CONTACTS PF | blink™C L Lubricant Eye Drops | Similar, different |
| packaging | |||
| Indications for Use | MaxiTears® CONTACTS PF eye drops | ||
| have been formulated for use with both | |||
| soft and rigid gas permeable (RGP) | |||
| contact lenses, to rewet lenses before | |||
| insertion and lubricate lenses during | |||
| wear. It also relieves minor irritation, | |||
| discomfort, dryness, blurring and | |||
| itchiness, which may occur while | |||
| wearing your lenses. | Use blink™ CL Lubricant Eye Drops | ||
| to lubricate and rewet soft and rigid | |||
| gas permeable (RGP) contact lenses; | |||
| to help relieve dryness, irritation | |||
| and discomfort that may be | |||
| associated with lens wear; and to | |||
| cushion lenses by placing a drop on | |||
| the lens prior to application on the | |||
| eye. | Similar, the | ||
| indications for use | |||
| are both for eye | |||
| lubricant on soft | |||
| and rigid gas | |||
| permeable lenses | |||
| Clinical Indication | Relief of symptoms of eye dryness and irritation due to environmental | ||
| conditions of the eye caused by Contact Lenses | Same | ||
| Volume / Bottle | 5x, 20x or 60x 0.4 mL , single-use | ||
| vials | 2 mL (0.06 fl oz), multi-use | ||
| 10 mL (0.34 fl oz) multi-use | Similar | ||
| Overall Design | Sterile, Buffered, Isotonic, Aqueous | ||
| Solution | Sterile, Buffered, Isotonic, Preserved | ||
| Aqueous Solution | Similar | ||
| Appearance | Clear, coloriess solution packaged in | ||
| single-use plastic vials (single dose | |||
| units) | Clear, colorless solution packaged in | ||
| plastic bottles with controlled dropper | |||
| tips | Same | ||
| Active ingredients | No | No | Same |
| Preserved | No | OcuPure (Oxychloro Complex 0.005 %) | NA |
| Humectant | Sodium hyaluronate | Sodium hyaluronate | Same |
| Osmolality | 270-330 mosmol/kg | 267 mosmol/kg | Similar |
| Buffered | Yes, pH 6.8-7.6 | Yes, pH 7.2 | Similar |
| Sterile | Yes, aseptic filling | Yes, aseptic filling | Same |
| Shelf Life | 2 years | > 9 month | |
| 45 days after opening | Similar | ||
| Biocompatibility | Yes, ISO 10993 series | Yes, ISO 10993 series | Same |
Table 5A – Comparison of Characteristics
6
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of MaxiTears CONTACTS PF and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Omnivision AG completed a number of non-clinical performance tests. The MaxiTears CONTACTS PF meets all the requirements for overall design, sterilization and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.
The MaxiTears CONTACTS PF passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility evaluation and biocompatibility testing of MaxiTears CONTACTS PF lens drop . solutions for patient-contacting materials including chemical characterization, genotoxicity, cytotoxicity, sensitization and irritation reactivity, subacute and systemic toxicity per ISO 10993-1, 3, 5, 10, 11, 12, 17, 18 ; PASSED all testing
- Cleaning and Sterilization Testing MaxiTears CONTACTS PF lens drop solutions are not sterilized in . their final packaging. The sterile bulk solution is stored under aseptic conditions within the storage tank and then for the filling process pushed through a sterile polypropylene filter 1.2µm to the sterilized blow-fill-machine under sterile nitrogen pressure. The sterility of the final solution is preserved by an overpressure sterile nitrogen flow. The filling is performed into natural plastic pellets, made of transparent LDPE, which were extruded at temperatures between 160 and 190 ℃. The molds which leave the extruder, immediately transformed into the 0.4ml Single Dose Unit (SDU)-blocks for MaxiTears CONTACTS PF. The blown SDU are sterile due to the high temperature applied. The devices are classified as Established Category A per the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Sterility tests are performed according USP39-NF34 ; PASSED all testing
- In vitro lens compatibility testing testing demonstrates physical product compatibility from . MaxiTears CONTACTS PF lens care solutions with both soft (hydrophilic) and RGP contact lenses according ISO 1198 and ISO 18369-2, -3; PASSED all testing
- . Shelf Life Testing - shelf life determination is based on real time as well as open vial (in-use) stability studies of the MaxiTears CONTACTS PF lens drop solutions performed in compliance with ICH guidance document Q1A and with ISO 13212:2014 Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life; PASSED all testing
- Storage and Transport Testing include transport validation under routine conditions with different lots . of manufactured MaxiTears CONTACTS PF assembled in different packaging variants to maintain integrity through normal shipping and handling; PASSED all testing
- Usability engineering testing per IEC 62366; PASSED all testing
- Risk Management per ISO 14971 and EN ISO 14971; all requirements were met and risks reduced as . far as possible.
7
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. This type of device, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the MaxiTears® CONTACTS PF and the predicate device blink™ CL Lubricant Eye Drops does not raise any questions regarding its safety and effectiveness. Technological product characteristics, performance testing and compliance with voluntary standards, demonstrate that the MaxiTears® CONTACTS PF are substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, of operation, performance characteristics, and intended use.
The MaxiTears CONTACTS PF, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.